Evaluation of safety and tolerability of the initial treatment with imatinib for chronic myeloid leukemia in chronic phase (Tokyo STI Study Group)
Phase 2
- Conditions
- Chronic myelogenous leukemia
- Registration Number
- JPRN-C000000352
- Lead Sponsor
- Tokyo STI Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1)Pregnant and/or lactating woman 2)WBC<3000/mm3 3)serum bilirubin or creatinine level above twice as the upper limit of normal 4)GPT or GOT level above 3 times as the upper limit of normal 5)PS >=3 6)In accelerate or blastic phase 7)Ph positivity <30 % by IFN-a treatment 8)Past history of BMT or PBSCT 9)Receiving investigational agents within 4 weeks 10)Grade 3 heart failure 11)Receiving another anti-leukemic therapy including IFN-a
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Optimal imatinib dosage based on the grading of adverse event at 6th months
- Secondary Outcome Measures
Name Time Method Hematological/cytogenetical response by imatinib dosage at 6 months